LONDON, April 26 European regulators have
recommended approval of two new cancer drugs, called Erivedge
and Xtandi, from Roche and Astellas,
underscoring a recent pick-up in novel treatments for the
Erivedge is the first medicine for people with advanced
forms of basal cell carcinoma, the most common skin cancer, and
was approved in the United States in January. Curis,
Roche's partner, is entitled to certain payments on the drug.
Xtandi, which Astellas has been working on with Medivation
, is designed to treat prostate cancer in men whose
cancer has spread despite treatment with hormone therapy and
chemotherapy. It won U.S. approval last August.
The European Medicines Agency said on Friday its experts had
also backed MAC1, a tissue-engineered medicine for cartilage
defects from Sanofi's Genzyme unit, and Spedra, a new
erectile dysfunction drug from Vivus.
Recommendations for marketing approval by the EMA's
Committee for Medicinal Products for Human Use (CHMP) are
normally endorsed by the European Commission within a couple of
In addition, the London-based agency recommended approval
for extended use of Celgene's blood cancer drug
Revlimid and Roche's rheumatoid arthritis treatment RoActemra.
The news was less good for Pfizer, whose new
arthritis pill Xeljanz received a surprise rejection from the
EMA, as announced by the company late on Thursday.